Fractyl Health (GUTS) Piper Sandler 36th Annual Healthcare Conference summary

Strategic focus and differentiation

• Focused on durable therapies for obesity and Type 2 diabetes, targeting root causes with procedural and gene therapies rather than traditional pharmaceuticals.

• Aims to provide long-lasting improvements in blood sugar and body weight, with solutions designed to last for years.

Key programs and 2025 catalysts

• Revita device targets the duodenum for metabolic reset; pivotal trials underway for Type 2 diabetes and weight maintenance after GLP-1 drug discontinuation.

• 2025 catalysts: Midpoint data from weight maintenance trial in Q2 and primary endpoint data from Type 2 diabetes trial in mid-2025.

• Rejuva gene therapy platform to initiate first-in-human study in H1 2025, focusing on Type 2 diabetes with potential for obesity treatment.

Rejuva gene therapy design and regulatory path

• Utilizes AAV9 vector with human insulin promoter driving GLP-1, delivered via outpatient endoscopic procedure.

• Targets GLP-1 expression levels similar to those seen after bariatric surgery, aiming for efficacy in blood sugar and weight control.

• Initial proof-of-concept study to be conducted in Europe, starting with Type 2 diabetes patients acclimatized to GLP-1 drugs.

• Regulatory framework for weight maintenance being established through Revita pivotal trial, with FDA breakthrough designation.